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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS SM IL SG VLV UTZ CATH ACC CERTAS PLUS SMALL & RA W/SG

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INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS SM IL SG VLV UTZ CATH ACC CERTAS PLUS SMALL & RA W/SG Back to Search Results
Catalog Number 828816
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Swelling (2091)
Event Date 10/30/2020
Event Type  Injury  
Manufacturer Narrative
An investigation has been initiated based on the reported information. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
A physician reported that the certas valve was implanted to a (b)(6)-old girl via v-p shunt on (b)(6) 2020 with unknown settings. After placing the valve, the hydrocephalus symptoms recovered. In the middle of (b)(6), csf retention under the skin around the valve and swelling were observed. Although the patient's condition was stable, on (b)(6) 2020, the valve (with a setting of 5) was replaced with a new one. No further information was provided by hospital.
 
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Brand NameCRTS SM IL SG VLV UTZ CATH ACC
Type of DeviceCERTAS PLUS SMALL & RA W/SG
Manufacturer (Section D)
INTEGRA LIFESCIENCES SWITZERLAND SAR
rue girardet 29
rue girardet 29
le locle
SZ
Manufacturer (Section G)
INTEGRA LIFESCIENCES SWITZERLAND SAR
rue girardet 29
ch-2400
le locle
SZ
Manufacturer Contact
vivian nelson
325 paramount drive
raynham, MA 02767
6099362319
MDR Report Key10877502
MDR Text Key217458649
Report Number3013886523-2020-00210
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number828816
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/09/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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